Sucralfate

Product NDC: 65162-062
11-digit product format: 651620062
Labeler code: 65162
Product ID: 65162-062_71ed86a3-ff8a-4545-9bae-26632466fd80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sucralfate Oral
Dosage form: SUSPENSION
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA209356
Marketing category: ANDA
Marketing start: 2019-12-02
Substance: SUCRALFATE
Active strength: 1 g/10mL
Pharmacologic classes: Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209356-001	SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2019-12-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A209356-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209356-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209356-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209356-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209356-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209356-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209356-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209356-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209356-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209356-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209356-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209356-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209356-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209356-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209356-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209356-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209356-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209356-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209356-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209356-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209356-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209356-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209356-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209356-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209356-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209356-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209356-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209356-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209356-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209356-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209356-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209356-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209356-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209356-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209356-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209356-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209356-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209356-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209356-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209356-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209356-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Sucralfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SUCRALFATE	1 g/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XX73205DH5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313123	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4350b771-76a9-4e00-93f0-a18c71288f83	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
01e96ee1-fe82-0132-025c-ec1559bf8b6e	Product name	5	20260127
f9fa5fa8-e047-2182-3e2c-c4a9ec6531cd	Product name	3	20240508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-062-05	Sucralfate	420 mL in 1 BOTTLE	SUSPENSION	420	18
65162-062-47	Sucralfate	10 mL in 1 CUP, UNIT-DOSE	SUSPENSION	10	18
65162-062-48	Sucralfate	10 in 1 TRAY	SUSPENSION	10	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-062-05	ML - Milliliter	65162-062	ff5e5cbb-cdbc-4017-bc65-9814869f19cd	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-062	SUCRALFATE (SUCRALFATE ORAL) SUSPENSION [AMNEAL PHARMACEUTICALS LLC]	18	Current NDC, Legacy NDC, 3 package rows	20241031_4350b771-76a9-4e00-93f0-a18c71288f83.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE ORAL	Cardinal Health 107, LLC	a0c9f585-1007-4996-aef7-e17cd55d28cd	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209356 application number: ANDA209356
Sucralfate	SUCRALFATE ORAL	AvKARE	c019bf24-8273-8d2f-e053-2a95a90aec98	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209356 application number: ANDA209356
Sucralfate	SUCRALFATE ORAL	AvPAK	e78ef7d4-faa7-aebf-e053-2995a90a6f84	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209356 application number: ANDA209356
Sucralfate	SUCRALFATE ORAL	Precision Dose, Inc.	0dc592e9-541c-4fac-8ab5-829d43521c01	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209356 application number: ANDA209356
Sucralfate	SUCRALFATE ORAL	Amneal Pharmaceuticals LLC	4350b771-76a9-4e00-93f0-a18c71288f83	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209356 application number: ANDA209356 ndc (product): 65162-062

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XX73205DH5	SUCRALFATE	54182-58-0	SUCRALFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313123	sucralfate 1 GM in 10 mL Oral Suspension	PSN	4350b771-76a9-4e00-93f0-a18c71288f83	18
313123	sucralfate 100 MG/ML Oral Suspension	SCD	4350b771-76a9-4e00-93f0-a18c71288f83	18
313123	sucralfate 1 GM per 10 ML Oral Suspension	SY	4350b771-76a9-4e00-93f0-a18c71288f83	18
313123	sucralfate 1 GM in 10 mL Oral Suspension	PSN	0dc592e9-541c-4fac-8ab5-829d43521c01	2
313123	sucralfate 1 GM in 10 mL Oral Suspension	PSN	573f74bc-6a49-4412-9eee-427536079851	2
313123	sucralfate 100 MG/ML Oral Suspension	SCD	0dc592e9-541c-4fac-8ab5-829d43521c01	2
313123	sucralfate 100 MG/ML Oral Suspension	SCD	573f74bc-6a49-4412-9eee-427536079851	2
313123	sucralfate 1 GM per 10 ML Oral Suspension	SY	0dc592e9-541c-4fac-8ab5-829d43521c01	2
313123	sucralfate 1 GM per 10 ML Oral Suspension	SY	573f74bc-6a49-4412-9eee-427536079851	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-062-05	65162006205	420 mL in 1 BOTTLE (65162-062-05)	420 ml	2019-12-02	0000-00-00	No	No	Current
65162-062-47	65162006247	10 mL in 1 CUP, UNIT-DOSE	10 ml					Historical
65162-062-48	65162006248	10 CUP, UNIT-DOSE in 1 TRAY (65162-062-48) / 10 mL in 1 CUP, UNIT-DOSE (65162-062-47)		2019-12-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sucralfate Oral Suspension 1 g/10 mL	Precision Dose, Inc.	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	2
Sucralfate Oral Suspension	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals, LLC	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	18
Sucralfate Oral Suspension Rx Only	AvPAK	2024-01-08	HUMAN PRESCRIPTION DRUG LABEL	3
Sucralfate Oral Suspension	ATLANTIC BIOLOGICALS CORP.	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	2